Any recent experience with Stem Cell (Prochymal) Therapy?

I'm starting this stem cell trial on Monday. Anyone have any recent experience to share? It's been a long wait to start because I had to drop my prednisone to 20mg even though I'm flaring for months.

clinicaltrials.gov/ct2/show/NCT00482092
www.osiris.com/prod_crohns.php

Are you in the 603 trial? I did it a few years back... They had to shut it down for a while, but I did hear from Osiris that it's up and running and they are 2/3 through with Phase 3. (Fast track).

I was in the older format of the study, so there were 3 dose arms=high dose, low dose and placebo. I don't know what I received, but I am sure it was the real cells because nothing has worked for me but Prochymal. I was at a colonoscopy center, so one scope at day 0 and another at day 30. I healed 50-60% in 30 days... It was amazing. I could feel the difference early on, maybe after the second or third infusion (at about 1.5 weeks).

I'd *love* to hear how you do on the trial... It's something I follow very closely. I can't wait for it go be submitted. I have no doubt it will be and the safety profile so far is excellent. (CT at 1 yr and 2 yrs, as you probably know). There's some negative press out there, but I know without a doubt how much it helped me.

Good luck!

So they did remove the low dose arm. I figured that was what they decided to do... 50-50 is pretty good! And open label even better... They closed the trial site I was at. But, they also told me they'd cancelled the open label. Guess I'll be calling Osiris Monday ;-) I completed both 603 and 610, which was the follow-up to 603 (if you responded) in the initial trial design.

If you are scheduled to receive a scope at day 30 and don't, they may withhold the open label. I'd just ask to make sure you are aware of the situation. They may have changed colonoscopy rules too. But, I know they are pushing hard for FDA approval and the scope is 100% objective, as opposed to CDAI.

I wish they'd relax the inclusion criteria so it would complete phase 3 more quickly! It's only those of us who have failed every thing... Have you also failed a steroid? I think they can bend that one by the fact that steroids don't really keep us in remission. (I broke out in head to toe hives after my first day of prednisone! I take methylprednisolone now when I need it)

I don't know if you found my posts from when I was in the trial... But, the infusions are pretty easy. I think I remember an hour drip? But, they can't call the blood bank (where they store the cells) until you arrive. So, there's a wait up front while they defrost and deliver the cell bag. Bring lots of entertainment. They also cover the infusion bag so that you can't see what's going into your vein.

You will smell for a day or two, but that's it. The first infusion I had I was panicked that I'd smell for weeks (the trial coordinators didn't have the answer to "how long?") My daughter always thought I smelled like creamed corn, but some people say garlic or oysters. It's from the DMSO they use to preserve. I'd imagine you read all that in your agreement.

Hello,

I'm having lots of pain with my Crohn's these days. I've been trying to peruse trials on the clinicaltrials.gov web site. I live in Seattle. I noted that sr5599 I believe did the PROCHYMAL trial in Seattle. I haven't noticed a Seattle location on the clinicaltrials.gov site. Any way to verify whether Seattle is a possibility? Also, can anyone clue me in to the risks associated with such a trial? I note the mention on this post of "603". What's that? Is this some sort of 2-step program?

On kind of a different note, I'd like to ask if anyone has any recommendations for pain meds. In retrospect, when I was hospitalized last year with obstruction, I got my first taste of dilaudid (sp?) pain med, and boy did that stuff work. It made me naseaus as heck, but they gave me Zofran I believe, which put a lid on the nausea immediately. My doc tells me that the dilaudid is a morphene based drug, so he won't give it to me as an outpatient. I've got lots of vicodin like pills and my dad's oxycontin (which I've never tried). My vicodin stuff (not exactly vicodin but something like it) gives me side effects, so I don't take anything. I wouldn't know how to take oxy, I just have a bunch because my dad took them all the time when he was very ill.

thanks!

Ahh, but I am so GLAD that they do require the colonoscopies!!!! Using the CDAI is such a poor "proof" of effectiveness. In my opinion all the CDAI does is allow approval of drugs that are no better than those already on the market and just a way to get another overly expensive drug approved and on the market.

rls - are you talking about the stem cell trial in Chicago? If so, this one is different - it's using Mesenchymal stem cells from adult bone marrow donors.

mark-seattle - the Seattle trial center closed down about a year ago. I just spoke to someone at Osiris last week. The "closest" trial center for us is San Fransisco.
603 is the name of the first "leg" of the trial. When I was in the trial, 2.5 years ago, if a patient responded to the dose arm in 603 then s/he was moved into the "610" trial (2nd portion). 610 was re-randomized and contained 3 treatments within a 2 year period. When they closed down the trial for re-design (when Seattle office also closed), the removed the re-randomization from 610. Now it's just anyone who completes 603 gets the open label treatments. Trust me - I tried because it's the only thing that helps me. I cannot get open label. So, maybe you could contact Seattle Gastro and see if they'd consider working with Osiris to re-open the Seattle trial center. Dr. Putnum was the GI in charge of the trial. Not sure it will happen, but I always figure it can't hurt.
Also - I agree that you should ask your doc for pain management that works for you. The Rx I have for Norco (hydrocodone/acetaminophen) makes my life so much easier...

Dave123- I love hearing the tale... The smell is so worth the benefits and even if you get a placebo in 603, you will *know* what the real deal is like in a short month! I am so excited to hear...

You got it. You just need to complete the first arm 603 to start 610, no level of response needed.

There are a couple of screening visits where they run tests prior to starting the treatments. And there are 4 (all day) infusions over a three week period so it might be hard to do from far away. You'd likely need to make at least 5 or 6 trips to San Fran over a month and a half.

Hey Dave... Any updates? How are you feeling? You must be getting close to infusion #3?

I note that there are different types of stem cell treatments being tried, as sr points out "Mesenchymal stem cells from adult bone marrow donors" as one. I read the other day about one person having to have a kidney removed due to adverse affects of a stem cell trial. Any thoughts on how safe the stem cell trials are or what could go wrong? Are some types of stem cell treatments regarded as considerably safer than others, anyone know?

Thanks for the update, good luck in 3 weeks.

A quick update on the stem cell trial. I'm in the open label now which means I am definitely getting the real treatment, no placebo. I have had 2 of the 3 doses, 5 weeks apart. I believe there has been some improvement to my symptoms but not dramatic and certainly no remission. My weight stopped dropping and I even gained a few pounds. I am going to the bathroom less, although still a lot. the first signs of improvement came 2 weeks after the first treatment, then leveled off and started worsening around week 4. Got a little better following the second treatment at week 5. So maybe it's a matter of finding the right dosing and intervals like Remicade. I still have some hope and will finish out the last treatment, but I'm not close to remission. I'm considering trying SCD once the trial is over. I really want to get off the "short course" of pred I've been on for 8 months. I can feel the bone and joint damage happening.

Hi. Just wanted to share my current experience with prochymal. I was put into the prochymal trial 2 weeks ago. I was given four infusions over the last 2 weeks (D0, D4, D7, D14). I just received my fourth injection yesterday. These four infusions could be either the medication or the placebo. Then over the next 2 and a half months i get 3 more infusions which are guaranteed to be medicine. Im just not sure which days i get them yet.

Over the past two weeks my stool has definitely become less watery and i've had a slight reduction in frequency (from an average of 5 times a day to 3 times a day). Also i've started passing gas which has become unusual for me since i was diagnosed. The doctor seemed to be very optimistic yesterday because my blood tests showed a large reduction in my inflammatory markers. So he told me he'd be very surprised if i was placed in the placebo group. For now im just sitting back hoping that it continues to show results. I still don't leave my house but that might change soon.

Here's how i got to where i'm at if your interested: I was diagnosed with Crohn's disease a year ago, at the begining of april, at the age of 22. First i was put on Azacol along with 40mg of prednisone. I was taken off of Azacol about two months later because i wasn't getting any better. Then they tapered down my prednisone to 20mg and put me on Remicade. Over the three months of Remicade they taperd down my prednisone more until i was taken off of it completely. I didn't get any better from Remicade so they decided to change my medication to Cymzia and Methotrexate. I was on these for another 3 months but they also didn't seem to be working. I got my colonoscopy and it showed my symptoms weren't getting better. So, I was taken off the methotrexate and Cymzia and put on 6mp and Entocort. The 6mp gave me severe stomach pain and made me throw up so i was taken off of that and a few weeks later i got into this Prochymal study. Now the only thing I'm taking is the Entocort and the Prochymal.

hey guys, I see it has been a bit since the last update, any news? I'm anxious to hear please reply, thank you